Comparison Of Celecoxib 200 Mg Bid, Loxoprofen Sodium 60 Mg Tid And Placebo In Low Back Pain In Japan
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00141154
First received: August 30, 2005
Last updated: May 27, 2011
Last verified: May 2011
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Purpose
To verify the superiority of celecoxib (YM177) 200 mg bid to placebo in treatment of patients with low back pain as well as non-inferiority to loxoprofen sodium 60 mg tid.
| Condition | Intervention | Phase |
|---|---|---|
|
Low Back Pain |
Drug: Celecoxib Drug: Placebo Drug: Loxoprofen |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized, Multicenter, Active And Placebo Controlled Parallel Group Study To Evaluate The Efficacy And Safety Of Celecoxib (Ym177) 200 Bid Compared To Loxoprofen 60 Mg Tid In Patients With Low Back Pain |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients who have the major site of the low back pain at the 12th thoracic vertebra or lower
- Patients who have had low back pain for at least two weeks
Exclusion Criteria:
- Patients who have a previous history or complication of rheumatoid arthritis, spondylarthrosis with negative serum reaction (ankylosing spondylarthritis, psoriatic arthritis), metastasis of tumor, Paget's disease, fibromyalgia, tumor or infection of spinal cord or intervertebral disc, or any other disease which can cause systemic pain
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141154
Locations
| Japan | |
| Pfizer Investigational Site | |
| Funabashi, Chiba, Japan, 273-0035 | |
| Pfizer Investigational Site | |
| Funabashi-shi, Chiba, Japan | |
| Pfizer Investigational Site | |
| Matsudo-shi, Chiba, Japan | |
| Pfizer Investigational Site | |
| Fukuoka-shi, Fukuoka, Japan | |
| Pfizer Investigational Site | |
| Chitose, Hokkaido, Japan, 066-0026 | |
| Pfizer Investigational Site | |
| Sapporo, Hokkaido, Japan | |
| Pfizer Investigational Site | |
| Sapporo-shi, Hokkaido, Japan | |
| Pfizer Investigational Site | |
| Katougun, Hyogo, Japan, 673-1462 | |
| Pfizer Investigational Site | |
| Kobe, Hyogo, Japan, 650 0004 | |
| Pfizer Investigational Site | |
| Nishinomiya, Hyogo, Japan, 662-0838 | |
| Pfizer Investigational Site | |
| Sagamihara-shi, Kanagawa, Japan | |
| Pfizer Investigational Site | |
| Yokohama, Kanagawa, Japan | |
| Pfizer Investigational Site | |
| Yokohama-shi, Kanagawa, Japan | |
| Pfizer Investigational Site | |
| Hatogaya-shi, Saitama, Japan | |
| Pfizer Investigational Site | |
| Kumagaya-shi, Saitama, Japan, 3600012 | |
| Pfizer Investigational Site | |
| Kumagayashi, Saitama, Japan, 3600854 | |
| Pfizer Investigational Site | |
| Minamisaitama-gun, Saitama, Japan | |
| Pfizer Investigational Site | |
| Saitama-shi, Saitama, Japan | |
| Pfizer Investigational Site | |
| Tokorozawa, Saitama, Japan | |
| Pfizer Investigational Site | |
| ,Shinjyuku-ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Adachi-Ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Bunkyou-ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Edogawa-ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Itabashi-ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Koito-ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Meguro-Ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Nakano-ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Nerima-ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Ota-Ku, Tokyo, Japan, 145-0066 | |
| Pfizer Investigational Site | |
| Ota-Ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Setagaya-ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Shibuya-ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Shinagawa-ku, Tokyo, Japan, 140-0001 | |
| Pfizer Investigational Site | |
| Shinjyuku-ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Suginami-ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Sumida-ku, Tokyo, Japan, 131-0043 | |
| Pfizer Investigational Site | |
| Toyoshima-ku, Tokyo, Japan | |
| Pfizer Investigational Site | |
| Chiba, Japan, 266-0031 | |
| Pfizer Investigational Site | |
| Fukuoka, Japan | |
| Pfizer Investigational Site | |
| Fukuoka, Japan, 810-0004 | |
| Pfizer Investigational Site | |
| Tokyo, Japan, 140-0011 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00141154 History of Changes |
| Other Study ID Numbers: | A3191174 |
| Study First Received: | August 30, 2005 |
| Last Updated: | May 27, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Loxoprofen Celecoxib Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Central Nervous System Agents Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013